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5 Sep 2020, 4:06 pm
Author David Cane Licence CC BY-SA 2,0 Source Wikipedia Jane Lambert Intellectual Property Enterprise Court (HH Judge Melissa Clarke) DPA (London) Ltd v D'Aguanno and others [2020] EWHC 2374 (IPEC) (3 Sept 2020) This was an action for copyright infringement and breach of contract brought by a firm of architects against two of its former architectural designers and the company [read post]
4 Sep 2020, 6:23 am
Department of Health and Human Services (“HHS”) Secretary Alex Azar assured that the proposed rule “would give Medicare beneficiaries faster access to the latest lifesaving technologies . . . by delivering Medicare reimbursement at the same time as FDA approval. [read post]
3 Sep 2020, 6:20 pm
During the evaluation, BAuA identified further concerns for most of the examined Human Health (HH) endpoints, precluding final conclusions with regard to the hazard assessment of the substance. [read post]
2 Sep 2020, 5:47 am
On July 20, 2020, HHS amended the reporting requirements for PRF payment recipients. [read post]
1 Sep 2020, 10:00 pm
On September 1, 2020, the Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services (HHS) published an Agency Order temporarily stopping all residential evictions in the United States, in order to prevent the spread of COVID-19. [read post]
1 Sep 2020, 3:53 pm
The Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), is the federal agency responsible for ensuring the safety and effectiveness of medical products—drugs and medical devices—marketed in the United States. [read post]
31 Aug 2020, 10:26 am
Applicable facilities must also electronically report COVID-19 information, including suspected and confirmed resident and staff infections, in a standardized format specified by the HHS Secretary. [read post]
30 Aug 2020, 10:26 am
As part of the settlement, DUSA and its parent company, Sun Pharma, have agreed to enter into a Corporate Integrity Agreement with HHS-OIG. [read post]
30 Aug 2020, 3:53 am
To get your affidavit of support(Form I-864) approved, you need to meet the following criteria:You must be a lawful permanent resident or U.S. citizenYou must be at least 18 years oldYour income must be at least 125% of HHS poverty guidelines for your household size.If you’re in the military, your income must be at least 100% of HHS poverty guidelines.My Income Isn’t Enough For An Affidavit Of Support(Form I-864)Imagine trying to fill Form I-864 (affidavit of support)… [read post]
28 Aug 2020, 1:59 pm
HHS-OIG Special Agent in Charge Scott J. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
27 Aug 2020, 12:21 pm
A lawsuit against HHS argues that the rule violates Bostock. [read post]
26 Aug 2020, 10:01 am
” China’s accusation comes after it held three military exercises on Monday in Pacific waters, as well as after HHS Sec. [read post]
25 Aug 2020, 9:03 pm
Senate Committee on Health, Education, Labor, and Pensions Event Date: 04/15/2020 Location: Virtual Subject: Food Safety and Supply Chain Issues in Response to COVID-19 FDA Participant/Group: MARK MOORMAN; Non-FDA Participant/Group: Several representatives from the National Restaurant Association Event Date: 04/17/2020 Location: Virtual Subject: Food Safety and Supply Chain Issues in Response to COVID-19 FDA Participant/Group: KATHERINE SERRANO; MICHELLE RODRIGUEZ; DONALD… [read post]
Why is HHS blocking FDA from regulating some diagnostics, and how will this affect COVID-19 testing?
25 Aug 2020, 4:50 pm
HHS’s notice strips (or, if you prefer, narrowly interprets) the FDA’s authority to regulate LDTs. [read post]
